Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002356
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-11-02
Brief Title:
The Safety and Effectiveness of ISIS 2922 in Patients With AIDS Who Have Cytomegalovirus CMV of the Eyes
Sponsor:
Ionis Pharmaceuticals Inc
Organization:
NIH AIDS Clinical Trials Information Service
Study Overview
Official Title:
An Open-Label Study of the Safety and Efficacy of Intravitreal ISIS 2922 in Acquired Immune Deficiency Syndrome AIDS Patients With Cytomegalovirus Retinitis NOTE Restricted to Patients Who Rollover From Another Controlled ISIS 2922 Trial
Status:
COMPLETED
Status Verified Date:
1998-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluate the efficacy and safety of ISIS 2922 in AIDS patients with Cytomegalovirus CMV retinitis who are unresponsive or intolerant to ganciclovir andor foscarnet but are otherwise ineligible for ISIS Pharmaceuticals controlled trials OR who have failed ISIS 2922 therapy on another controlled clinical trial
PER 2896 AMENDMENT Patients must rollover from another ISIS 2922 controlled trial
PER 2896 AMENDMENT Patients must rollover from another ISIS 2922 controlled trial
Detailed Description:
Patients receive intravitreal injections of ISIS 2922 at doses of either 150 or 300 mcg depending on CMV retinitis location and extent of retinal involvement There is a 3-week Induction period followed by at least 18 weeks of Maintenance Induction is given on days 1 8 and 15 and Maintenance doses are given every 14 days beginning on day 29
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ISIS 2922-CS7 | None | None | None |